Immunizations

Title XVIII of the Social Security Act section 1862 (a)(1)(A). This section allows coverage and payment of those services that are considered to be medically reasonable and necessary.

Title XVIII of the Social Security Act section 1862 (a)(7). This section excludes routine physical examinations and services.

Title XVIII of the Social Security Act section 1833 (e). This section prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

CMS Pub 100-02 Medicare Benefit Policy Manual, Chapter 15 - Covered Medical and Other Health Services, Section 50.4.4.2 - Immunizations.

CMS Pub 100-02 Medicare Benefit Policy Manual, Chapter 16 - General Exclusions from Coverage, Section 90 – Routine Services and Appliances.

CMS Pub 100-04 Medicare Claims Processing Manual, Chapter 17 – Drugs and Biologicals, Section 40 – Discarded Drugs and Biologicals.

CMS Pub 100-04 Medicare Claims Processing Manual, Chapter 18 - Preventive and Screening Services, Section 1- Medicare Preventive and Screening Services and Section 10 – Pneumococcal Pneumonia, Influenza Virus, and Hepatitis B Vaccines.

CMS Transmittal No. 4292, Pub 100-04, Medicare Claims Processing Manual, Change Request #11293, May 3, 2019. Quarterly Update to the Medicare Physician Fee Schedule Database-July 2019 Update.

CMS Transmittal No, 857, effective date October 3, 2018 Change Request 10901 Local Coverage Determinations (LCDs) Implementation date January 8, 2019.

Italicized font represents CMS national language/wording copied directly from CMS Manuals or CMS Transmittals. Contractors are prohibited from changing national language/wording.

Vaccinations or inoculations are excluded as immunizations unless directly related to the treatment of an injury or direct exposure to a disease or condition as listed below. Preventive immunizations are not covered except for the following: pneumococcal, hepatitis B, and influenza virus vaccines. If a vaccine or inoculation is not covered, related charges are also not covered. (CMS Pub 100-02 Medicare Benefit Policy Manual, Chapter 15 – Covered Medical and Other Health Services, Section 50.4.4.2 – Immunizations.)

Each specific immunization has specific coverage criteria.
The following immunizations are covered post-exposure:

1. Tetanus, Diphtheria and Pertussis (Tdap) Vaccines and Tetanus Diphtheria (Td) Vaccines
   These injections are covered when given for an acute injury to a person who is incompletely immunized for tetanus.
   1. Recommendations on tetanus prophylaxis are based on the condition of the wound and the patient’s immunization history.
      1. For more serious wounds, toxoid should be administered if the patient has not had a booster dose within the past 5 years.
      2. A wound with any of the following clinical features is a tetanus-prone wound: more than 6
         hours old; stellate; avulsion; abrasion; greater than 1 cm deep; injury due to missile, crush,
         burn, or frostbite; signs of infection; devitalized tissue; or a wound which affords anaerobic
         conditions or which has been incurred in a circumstance with probability of exposure to
         tetanus spores.
      3. In cases of clean, minor wounds, tetanus toxoid should be administered only if the patient has not had a booster dose within the past 10 years.
   2. When a patient has not received primary immunization, or the primary immunization status is not known, and the patient has sustained a high-risk wound, administration of Tdap is recommended. Administration of Td may be appropriate based on the time since the patient received their last Tdap and the severity of the wound.
   3. When a tetanus booster is given to a patient in the absence of an injury/potential exposure, the injection does not meet the coverage criteria for Medicare (even though it may be appropriate preventative treatment). Preventative services should not be billed to Medicare.
2. Diphtheria antitoxin will be covered for the treatment of diphtheria. 
3. Hepatitis A vaccine

   Hepatitis A is an acute, usually self-limiting infection of the liver caused by hepatitis A virus (HAV). The virus has a worldwide distribution and causes about 1.5 million cases of clinical hepatitis each year. The disease burden due to hepatitis A in the United States has been estimated to be approximately 143,000 infections per year, of which 75,800 results in clinical hepatitis.
   Humans are the only reservoir of the organism. Transmission occurs primarily through the fecal-oral route, and is closely associated with poor sanitary conditions. The most common modes of transmission include close personal contact with an infected person and ingestion of contaminated food and water. The virus is shed in the feces of persons with both asymptomatic and symptomatic infection. Under favorable conditions HAV may survive in the environment for months. Blood born transmission of HAV occurs but is much less common.

   The average incubation period is 28 days but may vary from 15–50 days. Approximately 10–12 days after infection the virus can be detected in blood and feces. In general, a person is most infectious from 14–21 days before the onset of symptoms, through 7 days after the onset of symptoms. Once a person has had Hepatitis A, they have lifetime immunity, so vaccines are unnecessary for these individuals.

   Hepatitis A Vaccine will be covered for those patients who have been exposed either by close personal contact with an infected person or after ingestion of contaminated food or water.

   Several vaccines against hepatitis A are now available that are highly efficacious and provide long-lasting protection in adults and in children above one to two years of age. For those requiring both immediate and long-term protection, the vaccine may be administered concomitantly with Immune Globulin (IG).

   Immunization for adults, children and adolescents consists of a two-dose regimen with the second dose being administered 6-18 months later depending on the vaccine used.
   Examples of the vaccines available are:
             HAVRIX® (Hepatitis A Vaccine, Inactivated)
             VAQTA® (Hepatitis A Vaccine, Inactivated)

4. Rabies Prophylaxis
   Rabies is a disease that rarely affects humans. It is carried by animals and transmitted by bite or scratch. The most common carriers are skunks, foxes, bats, raccoons, or domestic animals that have had infectious encounters with a carrier. When a human has had an encounter with an animal, the physician can determine if the encounter was at high risk for rabies exposure.
   1. Post-exposure prophylaxis treatment utilizes two rabies immunizing products concurrently:
      1. Vaccines - induce an active immune response that requires about 7-10 days to develop but persists for as long as a year or more. Types can include:
         - Human Diploid Cell Rabies Vaccine (HDCV)
         - Rabies Vaccine, Adsorbed (RVA)
      2. Globulins - provide rapid passive immunity that persists for a short time (half-life of about 21 days). Types can include:
         - Rabies Immune Globulin (RIG)
         - Antirabies Serum, Equine (ARS) - preferred over RIG due to less side effects than RIG.
   2. Post-exposure injections are given in the following way:
      1. When the patient has not been previously immunized
         - RIG; half the dose IM, the other half in the wound (bite), on the day of the exposure; and
         - HDCV, IM, on the day of exposure and days 3, 7, 14, and 28.
      2. When the patient has been previously immunized
         - HDCV on the day of the exposure and day 3.
5. When immune globulin treatment is administered, see the policy Immune Globulins for coverage criteria. 
6. Drug Wastage
   Medicare provides payment for the discarded drug/biological remaining in a single-use drug product after administering what is reasonable and necessary for the patient’s condition. If the physician has made good faith efforts to minimize the unused portion of the drug/biological by how it is supplied; how patients are scheduled; and how it is ordered, accepted, stored, and used; Medicare will cover the amount of drug discarded along with the amount administered.  For further information, refer to national policy: CMS Pub 100-04 Medicare Claims Processing Manual, Chapter 17 – Drugs and Biologics, Section 40 – Discarded Drugs and Biologicals.
7. For coverage information regarding vaccinations for Influenza, pneumococcal pneumonia and hepatitis B see:
   CMS Pub 100-04 Medicare Claims Processing Manual, Chapter 18 - Preventive and Screening Services and CMS Pub 100-02 Medicare Benefit Policy Manual, Chapter 15 - Covered Medical and Other Health Services.

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Documentation Requirements
Documentation supporting the medical necessity of this item, such as diagnosis codes, must be submitted with each claim. Claims submitted without such evidence will be denied as being not medically necessary.

Documentation in the progress notes must identify the exposure, describe the wound, describe the immunization status of the patient, and be available if requested.

Claims for non-covered services do not have to be submitted to Medicare. When the patient requests a non-covered routine immunization service to be billed to Medicare for denial, indicate that by using the GY modifier.

Drug Wastage Documentation Requirements
Any amount wasted must be clearly documented in the medical record with:

• Date and time.
• Amount of medication wasted.
• The reason for the wastage.

Utilization Guidelines
All materials used to administer the injection are included in the CPT code.

CDC Centers for Disease Control and Prevention. Hepatitis A FAQs for the public. (2013). 1-8. Accessed on 10/03/2023.

CDC Centers for Disease Control and Prevention. Updated recommendations for use of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine in adults aged 65 years and older – advisory committee on immunization practices (ACIP), 2012. (Jun 2012). 61(25): 468-470.

Grabenstein, J. D. (1995). ImmunoFacts® vaccines & immunological drugs; facts and comparisons, inc.
https://www.wolterskluwer.com/en/solutions/ovid/immunofacts-vaccines-and-immunologic-drugs-754

Who position paper on hepatitis A vaccines: June 2012—recommendations. (2012). Weekly Epidemiology Record, 28-29(87):261-276.